Phase
Condition
N/ATreatment
Lu AF28996
Clinical Study ID
Ages 35-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants diagnosed with idiopathic PD (consistent with the UK PD Society BrainBank Criteria for the Diagnosis of PD), with not more than 1 first-degree relativewho has PD.
Participants must have a Modified Hoehn and Yahr score ≤4 in the OFF state and ≤3 inthe ON state, and a Mini Mental State Examination score >25.
The OFF/ON amplitude on the MDS-UPDRS Part III at screening must be minimum 30%difference.
Participants must experience recognizable and predictable motor fluctuations (withat least 1.5 hours of OFF periods in the awake time, including predictable morningOFF episodes), causing clinically significant disability during the 7-week ScreeningPeriod, as evaluated by the investigator. This will be documented using aparticipant ON/OFF state registration over 3 consecutive days prior to enrolment.
Allowed concomitant medication for PD during the study includes levodopa, monoamineoxidase B inhibitors, COMT inhibitors, anticholinergics, and amantadine. Dopamineagonists are not allowed and should be discontinued ≥4 weeks prior to dosing with LuAF28996 and until the end of the study.
Participants diagnosed with idiopathic PD (consistent with the UK PD Society BrainBank Criteria for the Diagnosis of PD), with not more than 1 first-degree relativewho has PD.
Participants must have a Modified Hoehn and Yahr score ≥2 to ≤4 in the OFF state and ≤3 in the ON state, a MDS-UPDRS Part IV, 4.5 score of 1 or 2, and a MDS-UPDRS PartIV, 4.2 score ≥2 (at least mild functional impact), and a Mini Mental StateExamination score >25 at the Screening Visit.
Participants must currently have a good response to levodopa and be receiving astable dose of levodopa (≥3 doses per day of levodopa/dopa decarboxylase inhibitortherapy or ≥3 doses per day of levodopa Extended-Release Capsules and LEDD between 400 and 1600, inclusive) for at least 4 weeks prior to screening.
Participants must experience recognizable and predictable motor fluctuations (with ≥3 hours of OFF periods in the awake time, including predictable morning OFFepisodes), causing clinically significant disability during 3 months prior toenrolment, as evaluated by the investigator. The criteria will be documented usingHauser Diary over 3 consecutive days prior to enrolment.
Participants must experience ≥1 hour daily ON time with troublesome dyskinesia (TD)in the awake time (TD/24 hours while awake) during the last 3 months prior toenrolment as evaluated by the investigator. The criteria will be documented usingthe Hauser Diary over 3 consecutive days prior to enrolment.
Allowed concomitant medication for PD during the study includes levodopa, dopamineagonists, if allowed daily dose, monoamine oxidase B inhibitors, COMT inhibitors,anticholinergics, and amantadine.
Exclusion
Exclusion Criteria:
The participant has or had one or more of the following conditions that areconsidered clinically relevant in the context of the study; other neurologicaldisorder, psychiatric disorder, seizure disorder or encephalopathy, respiratorydisease, hepatic impairment or renal insufficiency, metabolic disorder,endocrinological disorder, haematological disorder, infectious disorder, anyclinically significant immunological condition, or a history of narrow-angleglaucoma.
Participant has been treated with apomorphine (pen/pump), and/or inhaled levodopaand/or levodopa/carbidopa intestinal gel (LCIG),and/or subcutaneousfoslevodopa/foscarbidopa within 6 weeks prior to the Baseline Visit.
Participants formerly treated with oral or transdermal dopamine agonists must havediscontinued 4 weeks prior to screening.
Participant has a history of Dopamine Agonist Withdrawal Syndrome (DAWS) whendopamine agonists were previously discontinued or reduced.
Other inclusion and exclusion criteria may apply.
Study Design
Study Description
Connect with a study center
Caen Normandy University
Caen, Basse-Normandie 14033
FranceSite Not Available
Caen Normandy University
Caen 3029241, Basse-Normandie 14033
FranceSite Not Available
Curiositas-ad-sanum
Hamburg, 83527
GermanySite Not Available
Curiositas-ad-sanum
Hamburg 2911298, 83527
GermanySite Not Available
QPS Netherlands BV
Leeuwarden, 8934 AD
NetherlandsSite Not Available
QPS Netherlands BV
Leeuwarden 2751792, 8934 AD
NetherlandsSite Not Available
Hospital Vall d´Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Vall d´Hebron
Barcelona 3128760, 08035
SpainSite Not Available
Hosp. General Catalunya
Mira-Sol, 08195
SpainSite Not Available
Virgen Del Roccio
Sevilla, 41013
SpainSite Not Available
Virgen Del Roccio
Seville, 41013
SpainSite Not Available
Virgen Del Roccio
Seville 2510911, 41013
SpainSite Not Available
CenExel Los Alamitos
Los Alamitos, California 90720
United StatesSite Not Available
CenExel Los Alamitos
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesSite Not Available
Georgetown University
Washington D.C., District of Columbia 20007
United StatesSite Not Available
Georgetown University
Washington D.C. 4140963, District of Columbia 4138106 20007
United StatesSite Not Available
Velocity
Hallandale, Florida 33009
United StatesSite Not Available
Velocity
Hallandale Beach, Florida 33009
United StatesSite Not Available
Parkinson's Disease Treatment Center of SW FL
Port Charlotte, Florida 33980
United StatesSite Not Available
Velocity
Hallandale 4157898, Florida 4155751 33009
United StatesSite Not Available
Parkinson's Disease Treatment Center of SW FL
Port Charlotte 4169130, Florida 4155751 33980
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta, Georgia 30331
United StatesSite Not Available
Atlanta Center for Medical Research
Atlanta 4180439, Georgia 4197000 30331
United StatesSite Not Available
Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
United StatesSite Not Available
Hawaii Pacific Neuroscience
Honolulu 5856195, Hawaii 5855797 96817
United StatesSite Not Available
QUEST Research Institute
Farmington Hills, Michigan 48334
United StatesSite Not Available
QUEST Research Institute
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
Neurology Consultants of Nebraska
Omaha, Nebraska 68154
United StatesSite Not Available
Neurology Consultants of Nebraska
Omaha 5074472, Nebraska 5073708 68154
United StatesSite Not Available
Inland Nortwest Research
Spokane, Washington 99202
United StatesSite Not Available
Inland Nortwest Research
Spokane 5811696, Washington 5815135 99202
United StatesSite Not Available

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